Phase I Trial definition

Phase I Trial means a clinical trial of a Licensed Product in human patients conducted primarily for the purpose of determining the safety, tolerability and preliminary activity of the Licensed Product, including, without limitation, for determining the maximum tolerated dose, or optimal dose. For purposes of this Agreement, a Phase I trial shall specifically exclude a study in healthy volunteers.

Phase I Trial means a human clinical trial (whether a Phase Ia or a Phase Ib trial) in any country of the type described in 21 C.F.R. §312.21(a), or an equivalent clinical study required by a regulatory authority outside of the United States.

Phase I Trial means a clinical trial of a Licensed Product in human patients designated as a Phase I Trial and conducted primarily for the purpose of determining the safety of and/or the metabolism and pharmacologic actions of the Licensed Product in humans, as described under 21 CFR § 312.21(a) (as hereafter modified or amended) and any of its foreign equivalents. For purposes of this definition, Phase I Trial shall specifically exclude trials in healthy volunteers.

Examples of Phase I Trial in a sentence

• Results of a Phase I Trial of Concurrent Chemotherapy and Escalating Doses of Radiation for Unresectable Non-Small Cell Lung Cancer.

• A Phase I Trial of the Novel Proteasome Inhibitor PS341 in Advanced Solid Tumor Malignancies.

• Subsequently, the Bankruptcy Court adjourned the Phase I Trial to a date to be determined.

• Ct. Los Angeles County, March 24, 2005, Case No. BS 080548), Statement of Decision from Phase I Trial on Petitions for Writ of Mandate, pp.

• Field surveys identified the following invasive species as the most prominent within the Project Area: purple loosestrife (Lythrum salicaria), reed canary-grass, common reed grass (Phragmites australis), multiflora rose, common buckthorn, Tartarian honeysuckle (Lonicera tatarica), Morrow’s honeysuckle, Japanese stiltgrass (Microstegium vimineum), and oriental bittersweet (Celastrus orbiculatus).

More Definitions of Phase I Trial

Phase I Trial means a clinical study of a product in human subjects, wherever conducted in the world, which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, or that would otherwise satisfy the requirements of 21 C.F.R. § 312.21(a) in the United States or its foreign equivalent.

Phase I Trial means a clinical trial to study the pharmacology of a medicinal product when administered to humans, where the sponsor and investigator have no knowledge of any evidence that the product has effects likely to be beneficial to the subjects of the trial;

Phase I Trial means, as to a specific pharmaceutical product, a controlled and lawful study in humans of the safety of a pharmaceutical product that is prospectively designed to generate sufficient data (if successful) to commence a Phase II Trial (or foreign equivalent) of such product, as further defined in United States Federal Regulation 21 C.F.R. §312.21 or the corresponding regulation in jurisdictions other than the United States.

Phase I Trial means a clinical trial of a Product with the endpoint of determining initial tolerance, safety, pharmacokinetic or pharmacodynamic information in single dose, single ascending dose, multiple dose and/or multiple ascending dose regimens.

Phase I Trial means a human clinical trial in any country that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

Phase I Trial means a human clinical trial that would satisfy the requirements of 21 C.F.R. 312.21(a) (as amended or any replacement thereof), including an equivalent clinical trial conducted in a country other than the United States.

Phase I Trial means a human clinical trial conducted in any country that would satisfy the requirements for a Phase 1 study as defined in 21 CFR § 312.21(a) (or any amended or successor regulations).